Engraftment Syndrome Clinical Trial
Official title:
Budesonide Prophylaxis for Engraftment Syndrome After Hematopoietic Cell Transplantation
The purpose of this study is to determine if budesonide prophylaxis starting day 5 after transplant reduces engraftment fever in autologous and allogeneic stem cell transplant recipients.
| Status | Recruiting |
| Enrollment | 110 |
| Est. completion date | December 30, 2026 |
| Est. primary completion date | January 30, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - • Patients 18-80 years of age with a diagnosis of a hematological malignancy - Meet the BMT program criteria to undergo hematopoietic stem cell transplantation for hematologi malignancies Exclusion Criteria: - • Patients enrolled in investigational clinical trials - Sct for non hematologic malignancies |
| Country | Name | City | State |
|---|---|---|---|
| United States | Henry Ford Health System | Detroit | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Henry Ford Health System |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | non-infectious fever | non infectious fever defined as fever without identified infection that occurs up to 3 days prior and 10 days after the day of engraftment in patients on budesonide prophylaxis compared to patients who will not receive prophylaxis | 30 days post stem cell transplant |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00923845 -
Low-Intensity Stem Cell Transplantation With Multiple Lymphocyte Infusions to Treat Advanced Kidney Cancer
|
Phase 2 |